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Recruiting Phase 4 NCT06369870

Interpectoral-pectoserratus Plane Block for Minimally Invasive Aortic Valve Replacement Via Right Anterior Minithoracotomy

Trial Parameters

Condition Analgesic Effect
Sponsor Algemeen Ziekenhuis Maria Middelares
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 144
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-09-01
Completion 2027-11
Interventions
Levobupivacaine Hydrochloride 0.25 % Injectable SolutionSodium chloride 0.9%

Brief Summary

The goal of this clinical trial is to evaluate the analgesic effect of locoregional anaesthesia, specifically the interpectoral pectoserratus plane (IPP-PSP) block, in comparison to a placebo (sham block) after Aortic Valve Replacement via Right Anterior Minithoracotomy (AVR-RAT). The main question the trial aims to answer is: Can the IPP-PSP block effectively reduce opioid consumption within the first 48 hours after AVR-RAT surgery? The purpose is to understand the impact of the IPP-PSP block on postoperative pain. Therefore, the aim is to investigate the influence of the IPP-PSP block on the amount of pain medication administered during the patients' first 48 hours after surgery. Participants, who are scheduled for AVR-RAT surgery, will be randomly assigned to receive either the IPP-PSP block or the sham block. Researchers will compare opioid consumption among other outcomes, including differences in pain scores, incidence of nausea and vomiting, quality of recovery, quality of life, and the length of hospital stay between the two groups. Patients will be monitored during their hospitalization, and a follow-up phone call will be conducted 30 days after surgery.

Eligibility Criteria

Inclusion Criteria: * Adult patients (18 years of age or older); * Patients scheduled for minimally invasive aortic valve replacement via right anterior minithoracotomy; * Patients with American Society of Anesthesiologists (ASA) physical status classification II, III or IV; * Patients with European System for Cardiac Operative Risk Evaluation (EuroSCORE) 2 ≤ 4%; * Patient has given written, free and informed consent. Exclusion Criteria: * BMI \> 35; * Patients under legal protection (curatorship, guardianship); * Patients subject to a legal protection measure; * An adult who is incapable or unable to give consent; * Patients requiring emergency surgery within 24 hours; * Chronic opioid use (\> 3 administrations per week or continuous transdermal therapy, longer than the last 3 months); * Patients known with chronic pain; * Patients known with an allergy to levobupivacaine or drugs used as standard of care, including amongst others piritramide, dexamethasone, propofol, remifentanil, ro

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